Mixing system and valve assembly

ABSTRACT

A mixing system is disclosed in which the system comprises a source of bone-graft or bone-graft-substitute material, a liquid source, and a vacuum source, at least one of the source of bone-graft or bone-graft-substitute material and the liquid source being in communication with the vacuum source. A valve assembly also forms part of the system, the valve assembly having a valve movable between a first position in which a first fluid passageway is created between the source of bone-graft or bone-graft-substitute material and the vacuum, and a second position in which a second fluid passageway is created between the source of bone-graft or bone-graft-substitute material and the liquid source, wherein, in the second position, the valve seals off the first fluid passageway, the vacuum source being adapted to generate a negative-pressure environment, relative to atmospheric pressure, within the valve assembly while the valve is in the first position. Methods of utilizing the aforementioned system are also disclosed.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of the filing date of U.S.Provisional Patent Application No. 61/773,385, filed Mar. 6, 2013, thedisclosure of which is incorporated by reference herein.

BACKGROUND OF THE INVENTION

The present invention(s) relates to apparatus and methods for mixingcertain substances, particularly substances usable for repairing orgrafting bone.

Bone-graft or bone-graft-substitute materials are used in manyapplications within the orthopedic and/or other medical fields, such asto cause fusion of adjacent bone parts to repair a fracture, to fuse ajoint(s) and alleviate pain at the joint(s), or more securely attach animplant or other device to bone. Indeed, such bone-graft orbone-graft-substitute materials have numerous indications within theorthopedic field, which rely on the ability of the material to inducenatural bone growth at the repair site (e.g., for regenerating and/orforming additional bone at the site). As an example, a bone-graftsubstitute currently offered by Orthovita, Inc., the assignee of thepresent application, comprises, in some cases, β-TCP (i.e., betatri-calcium phosphate), collagen, and/or bioactive glass. The bone-graftsubstitute, which is referred to as Vitoss® (manufactured by Orthovita,Inc., Malvern, Pa.) in the industry, has been shown to have superiorbone affinity and growth properties, and is used in various differentcontexts, such as a bone-void filler for voids or gaps in traumaapplications.

In the case of bone-graft or bone-graft-substitute material, it is alsosometimes preferable to mix such material with other compositions sothat the maximum effect is achieved. The other components of the mixturemay be a liquid, such as bone marrow aspirate, blood, saline, and/orwater. In the case of Vitoss®, when mixed with bone marrow, suchbone-graft substitute has proven a clinically effective autograftreplacement. Thus, Vitoss® is able to replicate natural bone takendirectly from the patient. In any case, prior to application of certainbone-graft or bone-graft-substitute materials, a surgeon, nurse, orother skilled operator (hereinafter “the user”) might be required to mixthe various components of the material so that, once applied to bone,the material induces the most-efficient bone formation.

While numerous mixing devices have been created for mixing bone-graft orbone-graft-substitute components, most require too many steps or areineffective in their application. Thus, there exists a need for animproved mixing system allowing for efficient mixing of the componentsof different bone-graft and bone-graft-substitute materials.

BRIEF SUMMARY OF THE INVENTION

One aspect of the present invention provides a method of mixingbone-graft or bone-graft-substitute material with one or more othercomponents. The method may comprise: (1) providing a source ofbone-graft or bone-graft-substitute material, and a source of liquid, atleast one of the source of bone-graft or bone-graft-substitute materialand the liquid source being in communication with a vacuum source; (2)moving a valve so that a first fluid passageway between the vacuumsource and the source of bone-graft or bone-graft-substitute material isopened; (3) using the vacuum source to create a vacuum between thesource of bone-graft or bone-graft-substitute material and the vacuumsource, the vacuum generating negative pressure, relative to atmosphericpressure, within the first fluid passageway; (4) sealing the first fluidpassageway to maintain the vacuum within the source of bone-graft orbone-graft-substitute material; and (5) moving the valve so that asecond fluid passageway between the source of bone-graft orbone-graft-substitute material and the liquid source is opened, whereinliquid from the liquid source is drawn into the second fluid passagewayand to the source of bone-graft or bone-graft-substitute material viathe negative pressure generated during the using step. The steps of themethod, of course, may take place in another order besides that setforth above.

In certain embodiments of this aspect, the method may also compriseproviding a valve assembly having internal channels that facilitatecreation of the first and second fluid passageways, wherein at leastsome of the internal channels house the valve. In addition, the sourceof bone-graft or bone-graft-substitute material, the liquid source, andthe vacuum source may all be syringes connected to a valve assemblycontaining the valve. What is more, the bone-graft orbone-graft-substitute material may comprise natural bone particles,particles of β-TCP, or hydroxyapatite combined with β-TCP, each of suchmaterials optionally including bioactive glass, and the liquid sourcemay comprise water, saline, blood, bone marrow aspirate, or acombination thereof. The bone-graft or bone-graft-substitute materialcan further be mixed with gelatin, collagen, micro-fibrillar collagen,or a combination thereof.

Another aspect of the invention includes a system for mixing abone-graft or bone-graft-substitute material with one or more othercomponents, the system comprising: (1) a source of bone-graft orbone-graft-substitute material, a liquid source, and a vacuum source, atleast one of the source of bone-graft or bone-graft-substitute materialand the liquid source being in communication with the vacuum source; and(2) a valve assembly having a valve movable between a first position inwhich a first fluid passageway is created between the source ofbone-graft or bone-graft-substitute material and the vacuum, and asecond position in which a second fluid passageway is created betweenthe source of bone-graft or bone-graft-substitute material and theliquid source. The valve according to this aspect, in the secondposition, may also seal off the first fluid passageway, and the vacuumsource may be adapted to generate a negative-pressure environment,relative to atmospheric pressure, within the valve assembly while thevalve is in the first position.

As with the previous aspect, the valve assembly may include a series ofinternal channels, at least some of which house the valve so that thevalve is movable from the first position to the second position. Thevalve, in one embodiment, is also movable from the first position to thesecond position against the force of a compressible member acting on asurface of the valve. Other features of this aspect are not detailedhere, but may be found below in the detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete appreciation of the subject matter of the presentinvention(s) and of the various advantages thereof can be realized byreference to the following detailed description in which reference ismade to the accompanying drawings in which:

FIG. 1 is a side view of a mixing system, according to one embodiment ofthe present invention.

FIG. 2 is a perspective view of a valve assembly forming part of themixing system of FIG. 1.

FIG. 3 is a cross-sectional view of the valve assembly of FIG. 2 shownwith the valve in an open or resting condition, while FIG. 4 is across-sectional view of the valve assembly of FIGS. 2-3 shown with thevalve in an engaged position.

FIGS. 5A-B are cross-sectional views of the mixing system of FIG. 1showing the vacuum syringe as being engaged to the valve assembly.

FIGS. 5C-D are cross-sectional views of the mixing system of FIG. 1showing the plunger of the vacuum syringe being withdrawn to create avacuum between the vacuum syringe and the morsel or bone-graft syringe.

FIG. 5E is cross-sectional view of the mixing system of FIG. 1 with afluid path being created between the morsel or bone-graft syringe andthe liquid syringe (e.g., through the valve assembly of FIGS. 2-4).

FIGS. 5F-G are cross-sectional views of the mixing system of FIG. 1 withmixing occurring between the morsel or bone-graft syringe and the liquidsyringe.

DETAILED DESCRIPTION

In describing the preferred embodiments of the invention(s), specificterminology will be used for the sake of clarity. However, theinvention(s) is not intended to be limited to any specific terms usedherein, and it is to be understood that each specific term includes alltechnical equivalents, which operate in a similar manner to accomplish asimilar purpose.

As an example, the term “distal,” as used herein, means relativelyfarther from a user, while the term “proximal” means relatively closer.In addition, use of the term bone-graft material herein is intended torefer to natural bone-graft substances, such as allograft, autograft, orother natural bone substances, while the term bone-graft-substitutematerial is intended to refer to synthetic materials acting as asubstitute for natural bone, such as hydroxyapatite, β-TCP, or the like.Vitoss® is an example of such a bone-graft-substitute material. Further,use of the term “fluid path” herein is intended to refer to anypassageway in which a fluid may flow from one area to another, the fluidbeing any fluid, such as, for example, a liquid or air.

Referring to FIG. 1, a mixing system 10 is shown in which the system 10comprises a set of syringes 12, 14, 16 connected, respectively, to avalve assembly 50 that allows mixing of components therein (e.g.,bone-graft or bone-graft-substitute material along with othercomponents, etc.) In one embodiment, syringe 12 may be filled withbone-graft or bone-graft-substitute material, such as Vitoss®, syringe14 may be filled with a liquid, and syringe 16 may be used to create avacuum and affect mixing between the components in syringes 12, 14.Thus, in use mixing system 10 may mix certain components of differentbone-graft or bone-graft-substitute materials, or even other materials,with less steps and greater efficiency than prior systems.

Turning to FIG. 2, valve assembly 50 may include a series of branches52, 54, 56, 58 extending from its center, three (3) of which 52, 54, 56may contain an opening 60, 62, 64 at an end thereof. In one embodiment,branch 58 of valve assembly 50 may be closed or sealed off, as shown. Inaddition, adjacent openings 60, 62, 64 may be a set of Luer fittings 66,68, 70 adapted to mate with corresponding Luer structure formed on aportion of syringes 12, 14, 16 (described in detail below). In oneembodiment, branches 52, 54, 56, 58 are a unitary structure that forms across-shape.

As shown in FIG. 3, branches 52, 54, 56, 58 of valve assembly 50 mayalso each include an internal bore or channel 72, 74, 76, 78, some ofwhich 72, 74, 76 communicate with the atmosphere via openings 60, 62,64. A valve 80 is also situated within assembly 50, in particular withininternal bores 74, 78 of branches 54, 58, such that valve 80 is movablevertically within branches 54, 58. In one embodiment, valve 80 isengaged with a spring 82 arranged in internal bore 78 of branch 58, suchthat valve 80 may be compressed against spring 82. Spring 82 may, insome cases, be a helical compression spring that sits upon a floorsurface 84 of branch 58 of valve assembly 50, such that spring 82 iswedged between valve 80 and floor surface 84. In other variants, spring82 is simply a deformable or compressible material (e.g., a compressiblesolid) that compresses upon movement of valve 80 within internal bore 78of branch 58. Stated differently, spring 82 may be any member suitableto allow movement of valve 80 within internal bore 78 and return valve80 to its initial condition. In other embodiments, valve 80 itself maybe a compressible structure, allowing movement of a portion of valve 80vertically within branches 54, 58. Indeed, while spring 82 is referredto throughout the remainder of the disclosure, such reference is merelyexemplary, as any of the aforementioned structures may achieve a similarfunction.

Valve 80 also includes at least one opening 86, in one embodiment, theopening 86 extending entirely through valve 80 to allow a fluid path 92to be created (e.g., through internal bores 72, 76 of branches 52, 56and opening 86 of valve 80). Referring now to FIG. 4, valve 80 may alsoinclude a recessed area 88 and a step 90 formed between recessed area 88and the body of valve 80. Upon movement of valve 80 into internal bore78 of branch 58 (e.g., via compression of spring 82), a separate fluidpath 94 may be created along internal bores 72, 74 of branches 52, 54.Further, recessed area 88 and step 90 of valve 80 may serve to redirectfluid upon the proper path 94, while the remainder of valve 80 may blockfluid transfer into other branches 56, 58 of valve assembly 50 whilefluid path 94 is open. Stated differently, due to the geometry of valve80, when fluid path 94 is opened, fluid path 92 through branches 52, 56and opening 86 of valve 80 may be closed or sealed. This is due, atleast, to the fact that opening 86 may be entirely positioned withininternal bore 78 of valve assembly 50 once fluid path 94 is opened(e.g., via movement of valve 80 into branch 58 through compression ofspring 82).

As shown in FIG. 5A, valve assembly 50 may also be connectable tosyringes 12, 14, 16 by way of Luer fittings 66, 68, 70 on branches 52,54, 56. Indeed, a distal end of each syringe 12, 14, 16 may include anozzle 36, 38, 40 and a surrounding cylindrical wall with internal Luerstructure 30, 32, 34 for engaging with Luer fittings 66, 68, 70 of valveassembly 50. Thus, a user may simply screw each syringe 12, 14, 16 onbranches 52, 56, 54, respectively, to engage syringes 12, 14, 16 withvalve assembly 50. In one embodiment, Luer connections 30, 32, 34 onsyringes 12, 14, 16, may comprise internal threading (as is known in theart), and Luer fittings 66, 68, 70 on valve assembly 50 may be a lip(s)projecting from branches 52, 54, 56 for engaging with such threading.Once syringes 12, 14, 16 are connected to valve assembly 50, asdescribed above, mixing system 10 may be constructed and ready foroperation.

One embodiment of a method of utilizing mixing system 10 to mixbone-graft or bone-graft-substitute material 24 with a liquid 26 willnow be described in connection with FIGS. 5A-G.

Initially, a user may place a certain amount of bone-graft orbone-graft-substitute material 24 within syringe 12. This may be done,alternatively, during manufacture of syringe 12. In one embodiment, thebone-graft or bone-graft-substitute material 24 may be in particulateform according to one or more of the following sizes (or a combinationthereof): (1) morsel—about two to about four millimeters (≈2-4 mm) indiameter; (2) micro-morsel—about one to about two millimeters (≈1-2 mm)in diameter; and/or (3) fine particulate—less than about one millimeter(<≈1 mm) in diameter. Other particulate sizes for bone-graft orbone-graft-substitute material 24 are also contemplated, of course.Further, bone-graft or bone-graft-substitute material 24 may be mixedwith one or more of a number of materials, such as gelatin, collagen,micro-fibrillar collagen, or the like. In a particular embodiment, themicro-fibrillar collagen used may be any of the collagen compositionsdetailed in U.S. Pat. Nos. 6,096,309 and 6,280,727, the disclosures ofwhich are hereby incorporated by reference herein.

It is also noted that a Vitoss® product may be placed in syringe 12 asmaterial 24. Indeed, material 24 may be a Vitoss® product in morsel,micro-morsel, and/or fine particulate form along with or apart fromgelatin, collagen, micro-fibrillar collagen, or the like. In a preferredembodiment, bone-graft or bone-graft-substitute material 24 is a Vitoss®product, in fine particulate form, which is mixed with gelatin,collagen, and/or micro-fibrillar collagen and then lyophilized into acomposite material in morsel, micro-morsel, and/or fine particulateform. Such composite particles of material 24, in this embodiment, mayalso have a size range of anywhere between about zero to about tenmillimeters (≈0-10 mm) in diameter, with a preferred size range ofanywhere between about five one-hundredths to about three millimeters(≈0.5-3 mm) in diameter. The bone-graft or bone-graft-substitutematerial(s) 24, according to this or other embodiments, can also includebioactive glass, as with several of the Vitoss® products (e.g., Vitoss®BA2X Bone Graft Substitute, etc.) The bioactive glass may be eithersolid or porous, and may have a size range of anywhere between aboutthirty two to about one-hundred fifty microns (≈32-150 μm) in diameter.

Certain Vitoss® compositions, any of which may encompass material 24,are described in detail in U.S. Pat. Nos. 6,383,519 and 6,521,246, thedisclosures of which are hereby incorporated by reference herein.Further, the particular Vitoss® composition utilized, in one embodiment,may be modified or combined with various natural and synthetic polymers,film-forming materials, resins, slurries, aqueous mixtures,pre-polymers, organic materials, metals, and other adjuvants. Inparticular, materials such as collagen, wax, glycerin, gelatin,polycaprolactone, carboxymethylcellulose, pre-polymeric materials (e.g.,precursors to various nylons, acrylics, epoxies, polyalkylenes, and thelike), may permeate all or part of material 24, which may be formed inaccordance with the '519 and '246 Patents. The bone-graft orbone-graft-substitute material 24 of the present invention can alsoinclude any of the shaped bodies disclosed in U.S. Pat. Nos. 7,189,263,7,531,004, and 8,303,967, the disclosures of which are herebyincorporated by reference herein.

Once a particular bone-graft or bone-graft-substitute material 24 isplaced within syringe 12, syringe 12 may be connected to valve assembly50 by engaging its Luer structure 30 with the corresponding Luer fitting66 on branch 52. Then (or alternatively before or at the same time),liquid 26 may be placed in syringe 14. Liquid 26, in certainembodiments, may be water, saline, blood, bone-marrow aspirate,platelet-rich plasma (PRP), certain sugar or salt solutions, such aspotassium and dextrose solutions, or any combination thereof. Liquid 26may also contain antibiotics, bone morphogenic proteins (BMPs), or otherdrugs or biologics. Syringe 14 is then connected to valve assembly 50 atbranch 56 by way of its Luer connection 32 and the corresponding Luerfitting 70 on branch 56.

As shown by arrows 42 in FIG. 5A, syringe 16, which may be empty andinclude a plunger 22 that is fully or almost fully depressed, issubsequently connected to valve assembly 50 at branch 54, in particularthrough its Luer connection 34 and the corresponding Luer fitting 68 onbranch 54. This connection is shown in detail in FIG. 5B. Prior to fullengagement of syringe 16 to valve assembly 50 (which is shown inprogress in FIG. 5B), valve 80 may be in its resting condition in whichspring 82 supports valve 80 so that opening 86 and internal bores 72, 76of branches 52, 56 are in fluid connection. Yet, as the internal spacewithin valve assembly 50 (e.g., the space within internal bores 72, 76and opening 86) is at virtually the same pressure as the space withineither of syringes 12, 14, no automatic fluid transfer occurs at thisstage (absent depression of one of plungers 18, 20 of syringes 12, 14,of course). Stated differently, bone-graft or bone-graft-substitutematerial 24 and liquid 26 may not mix at this stage (e.g., within valveassembly 50 or one of syringes 12, 14) since there is nothing to exerteither material 24, 26 into valve assembly 50 or syringes 12, 14 (again,absent actuation of plungers 18, 20). The system 10 is simply static.

As illustrated in FIGS. 5B and 5C, the user may then fully engagesyringe 16 with branch 54 of valve assembly 50, such that nozzle 38 ofsyringe 16 presses on a portion of valve to cause valve 80 to movewithin branch 58 (e.g., through compression of spring 82 against floorsurface 84). During such movement of valve 80, opening 86 may besituated entirely within branch 58, such that fluid path 92 is closedoff and a fluid path 94 (FIG. 5D) is created between syringes 12, 16. Inparticular, fluid path 94 may be created through nozzle 38 of syringe16, internal bore 74 of branch 54, recessed area 88 and step 90 of valve80, internal bore 72 of branch 52, and finally nozzle 36 of syringe 12.In an alternate embodiment, syringe 16 may be fully engaged with valveassembly 50, and valve 80 moved fully within branch 58 to open fluidpath 94, before connection of liquid syringe 14 with valve assembly 50.In this manner, liquid syringe 14 may initially be sealed off frominteraction with syringe 12 so that absolutely no transfer of liquid 26to syringe 12 occurs.

With fluid path 94 opened, the user may retract plunger 22 of syringe 16in the direction of arrow 44 in FIG. 5C to create a vacuum 28 amongstsyringes 12, 16 and valve assembly 50. Stated another way, retraction ofplunger 22 in the direction of arrow 44 may create a negative-pressureenvironment within the body of valve assembly 50 and syringes 12, 16(vacuum illustrated in FIGS. 5D-E is intended to indicate that syringe16 is used to create negative pressure amongst assembly 50 and syringes12, 16, and not to indicate that vacuum 28 is only present in syringe16). Thus, the space within nozzles 36, 38 and branches 52, 54 may besubject to a lower pressure than the atmosphere once plunger 22 ofsyringe 16 is retracted. In this manner, a vacuum 28 may be createdamongst syringes 12, 16 and valve assembly 50 so that negative pressureexists in those areas. Due to the fact that bone-graft orbone-graft-substitute material 24 may be in lyophilized composite form(e.g., Vitoss® mixed with gelatin, collagen, micro-fibrillar collagen,or the other such material(s), and then lyophilized), however, material24 may not be movable through nozzle 36 of syringe 12 absent saturationwith liquid 26. Thus, once vacuum 28 is created, material 24 may not beforced from syringe 12 through nozzle 36. Rather, material 24 may simplyremain in syringe 12 while being subject to pressure from vacuum 28.

With a negative-pressure environment present in valve assembly 50,syringe 16 may be withdrawn proximally along branch of valve assembly 50(e.g., unscrewed from branch 54), as shown in FIG. 5E. Indeed, syringe16 may be moved proximally by a distance sufficient to allow valve 80 tomove out of branch 58 via pressure exerted thereon by spring 82, thuscausing opening 86 of valve 80 to align with internal bores 72, 76 ofbranches 52, 56. Portions of valve 80, once moved proximally, may alsoseal off internal bore 74 of branch 54 from the remaining branches 52,56, 58 so that the vacuum 28 or internal negative pressure within valve50 is maintained. In addition, since syringe 14 was not previouslysubject to the effects of vacuum 28, and is therefore at a pressureroughly equal to the existing atmospheric pressure, liquid 26 may beforced from syringe 14 into valve assembly 50 along fluid path 92.Stated differently, as the pressure in syringe 14 is greater than thepressure within valve assembly 50 (e.g., via the effects of vacuum 28),liquid 26 will tend to be forced from syringe 14 and into valve assembly50 so that both pressures equalize. Also, since syringe 12 is atvirtually the same internal pressure as valve assembly 50, liquid 26 maybe forced into syringe 12 along fluid path 92 so that bone-graft orbone-graft-substitute material 24 is fully saturated with liquid 26,which in some cases may be water, saline, blood, bone marrow aspirate,PRP, certain sugar or salt solutions, or a combination thereof. As such,an initial mixing of material 24 and liquid 26 may take place withinsyringe 12 so that bone-graft or bone-graft-substitute material 24 gainsgreater bio-affinity by way of saturation with liquid 26. If desired,plunger 20 of syringe 14 may also be depressed in this sequence tofurther assist with transferring liquid 26 into syringe 12 to mix withmaterial 24. Since material 24 is saturated with liquid 26 during thisstep, as discussed above, material 24 may also become more fluid so thatit may easily exit syringe 12 via nozzle 36. Stated differently, whileprior to this step it may have been difficult to force material 24 fromsyringe 12 due to its solid or near-solid state (e.g., as a lyophilizedcomposite composed of morsels, micro-morsels, or fine particulateVitoss® mixed with any of the previously-described components, such asgelatin, collagen, micro-fibrillar collagen, or the like), aftersaturation with liquid 26 material 24 may be less viscous so thatmaterial 24/liquid 26 may be removed from syringe 12 through nozzle 36.In one embodiment, after saturation with liquid 26, material 24 maybecome a viscous gel, or a pliable mass of material that is able tofreely travel through nozzle 36 of syringe 12, valve assembly 50, and/orsyringe 14.

Actuation of plungers 18, 20, at this stage, may cause yet additionalmixing to occur along fluid path 92, as shown in detail in FIG. 5F. Amixture of material 24 and liquid 26 may then be created, such thatmaterial 24 is fully saturated or wetted with liquid 26, as representedby mixture 96 in FIG. 5F. During mixing to create mixture 96, certainportions of bone-graft or bone-graft-substitute material 24 (e.g.,Vitoss® mixed with gelatin, collagen, and/or micro-fibrillar collagenand then lyophilized) may dissolve or otherwise combine with fluid 26 sothat mixture 96 ultimately achieves the optimal viscosity to travelthrough the various components of system 10. Indeed, in a preferredembodiment, Vitoss® particles may form a core of the lyophilizedmaterial 24, with gelatin, collagen, and/or micro-fibrillar collagenforming the exterior, and the exterior may dissolve or otherwise combinewith liquid 26 once material 24 is wetted with liquid 26. In thismanner, the Vitoss® particles forming part of material 24 (which in someembodiments are in fine particulate form) may be smaller than thelyophilized composite material 24. Thus, upon dissolving portions of theexterior of material 24 (e.g., gelatin, collagen, and/or micro-fibrillarcollagen), the surviving Vitoss® core may more easily transfer amongstsyringes 12, 14 and valve assembly 50 due to its size. As notedpreviously, the surviving core of Vitoss® may also include bioactiveglass (porous or non-porous), of course.

The user, at his or her election, may transfer mixture back and forthbetween syringes 12, 14 as many times as necessary to achieve fullmixing of material 24 and fluid 26. In this manner, bone-graft orbone-graft-substitute material 24 may be adequately saturated withliquid 26 to create mixture 96 for application in many differentsurgical contexts, as detailed previously. If desired, during the mixingprocess syringe 16 may also be fully removed from connection with valveassembly 50, as shown in FIG. 5G, although this is not required.

At the end of mixing, as shown in FIG. 5G, mixture 96 may be transferredentirely to one of syringes 12, 14 (the transfer is shown as being tosyringe 12 in FIG. 5G) so that mixture 96 may be applied at the surgicalsite to create efficient bone growth or bone reformation. Thus, asdescribed, mixing system 10 allows a user to more efficiently mixcomponents of a bone-graft or bone-graft-substitute material forapplication in different surgical fields.

In the devices shown in the figures, particular structures are shown asbeing adapted for use in the mixing of certain substances according tothe present invention(s). The invention(s) also contemplates the use ofany alternative structures for such purposes, including structureshaving different lengths, shapes, and/or configurations. For instance,although syringe 16 is disclosed as being utilized to create a vacuum 28by manual means (e.g., retraction of plunger 22), it is contemplatedthat any vacuum means may be used, including an automated or electronicvacuum means. Thus, using such automated or electronic vacuum means, anylevel of vacuum (within certain limits, of course) may be createdamongst syringes 12, 16 and valve assembly 50. As such, additionalnegative pressure may be created in those areas so that, once valve 80is returned to its resting condition via the removal of syringe 16 fromconnection with valve assembly 50, liquid 26 may more easily flow fromsyringe 14 to syringe 12 along fluid path 92.

It is also the case that branch 56 (or any of the branches 52, 54, 56)may include a needleless valve to seal branch 56 when nozzle 40 ofsyringe 14 is not pushed through the needleless valve. Such structuremay be beneficial in creating yet additional vacuum pressure in system10. For instance, it is contemplated that, in one embodiment, syringes12, 16 may be connected to valve assembly 50, fluid path 94 opened (FIG.5D), and vacuum 28 created via retraction of plunger 22, but during thisprocess syringe 14 may not be connected to valve assembly 50. Rather,branch 56 may be sealed from the atmosphere via a needleless valve sothat syringe 16 may be retracted from connection with valve assembly 50(FIG. 5E), but no fluid path is created. Instead, plunger 22 of syringe16 may be depressed once more, syringe 16 reconnected to valve assembly50, and the vacuum process repeated (FIGS. 5C-D) to create additionalvacuum pressure 28 amongst syringes 12, 16 and valve assembly 50. Then,syringe 14 may ultimately be connected to valve assembly 50 through theneedleless valve within branch 56, fluid path 92 opened (FIG. 5E), andmixing may take place under additional vacuum pressure 28. Thus, such amethod provides an alternate means to generate further vacuum pressure28 within mixing system 10.

In the various vacuum pressure 28 generating steps discussed above, itis also possible to utilize a vacuum-lock syringe as syringe 16. Inother words, syringe 16 may include locking structure to maintainplunger 22 in its retracted position once vacuum 28 is created. As oneexample, plunger 22 may be retracted to create vacuum 28, and thenrotated to a locked position so that vacuum 28 is maintained, at whichpoint syringe 16 may be removed or withdrawn proximally along branch 54to open fluid path 92 for mixing of material 24 and liquid 26.

For exemplary purposes, branches 52, 54, 56, 58 of valve assembly 50 aredepicted with substantially equivalently sized diameters and internalbores 72, 74, 76, 78. However, it is envisioned that they may havedifferent sizes. For instance, branches 54, 58 and their internal bores74, 78 may have larger diameters than branches 52, 56 and their internalbores 72, 76, such that valve 80 may be large enough to accommodate anopening that is equal in diameter to internal bores 72, 76 whilemaintaining structural integrity of the valve 80.

As yet another example, in one embodiment branches 52, 56 of valveassembly 50, in particular internal bores 72, 76 thereof, may includebaffles or other mixing structure to assist with mixing of material 24and liquid 26 during transfer between syringes 12, 14. Further, althougha spring 82 is shown in the figures, alternate compressible structuresmay be used, so long as opening 86 of valve 80 may be entirelyencompassed within branch 58 to create the various fluid paths 92, 94.Stated differently, any compressible structure (including a compressiblevalve 80) may be used in place of spring 82 so long as the structureallows movement of valve 80 within branch 58 to open fluid path 94 andseal fluid path 92, and also return valve 80 to its resting condition inwhich fluid path 92 is open and fluid path 94 is sealed.

Alternates to valve 80 may also be used with system 10. For example, inone embodiment valve 80 may not include opening 86, but rather may bemovable vertically within branch to a degree such that fluid path 92 isopened. Indeed, spring 82 may be larger than in the previousembodiments, and valve 80 (without opening 86) may be movable withinbranch 54 so that a bottom surface of valve 80 is situated aboveinternal bores 72, 76 of branches 52, 56. In this manner, a portion ofspring 82 supporting valve 80 may be situated at the intersection ofbranches 52, 54, 56, 58, valve 80 may be positioned above suchintersection, and fluid path 92 may be opened so that liquid 26 and/ormaterial 24 can travel under valve 80 and through spring 82.

As a further example, the Luer structure utilized with mixing system 10(e.g., on syringes 12, 14, 16 and valve assembly 50) may be omitted, ifdesired, and syringes 12, 14, 16 may simply be press-fit onto branches52, 54, 56 of valve assembly 50. In other words, nozzles 36, 38, 40,along with their external cylindrical walls, may be configured to form afriction fit with branches 52, 54, 56 so that syringes 12, 14, can beconnected to valve assembly 50 to affect mixing of material 24 andliquid 26, as described above.

It should be noted, as well, that in certain embodiments valve 80 may berotatable within assembly 50, such that a fluid path (not shown) may becreated through internal bores 74, 76 of branches 54, 56. In such anembodiment, valve may be lockable in one orientation (e.g., to createfluid path 94), rotatable to a second orientation in which a separatefluid path (not shown) is created along internal bores 74, 76, andlockable in the second orientation to maintain the integrity of thefluid path.

Also, while certain steps of the above-described method(s) may have beendiscussed in a particular order, it is to be understood that the ordermay be altered in any manner suitable to mix the substances discussedpreviously. Thus, the order of steps for the method(s) is not essential,and such order may be varied or changed in any manner consideredsuitable by one of skill in the art.

Although the invention(s) herein has been described with reference toparticular embodiments, it is to be understood that these embodimentsare merely illustrative of the principles and applications of thepresent invention(s). It is therefore to be understood that numerousmodifications may be made to the illustrative embodiments and that otherarrangements may be devised without departing from the spirit and scopeof the present invention(s) as defined by the appended claims.

It will also be appreciated that the various dependent claims and thefeatures set forth therein can be combined in different ways thanpresented in the initial claims. It will also be appreciated that thefeatures described in connection with individual embodiments may beshared with others of the described embodiments.

The invention claimed is:
 1. A method of mixing bone-graft orbone-graft-substitute material with one or more other components, themethod comprising: providing a source of bone-graft orbone-graft-substitute material, and a source of liquid, at least one ofthe source of bone-graft or bone-graft-substitute material and theliquid source being in communication with a vacuum source; engaging asyringe with a valve assembly containing a valve to automatically movethe valve to a position in which a first fluid passageway between thevacuum source and the source of bone-graft or bone-graft-substitutematerial is open, wherein the valve automatically moves to a position inwhich the first fluid passageway is closed once the syringe is retractedproximally along the valve assembly; using the vacuum source to create avacuum between the source of bone-graft or bone-graft-substitutematerial and the vacuum source, the vacuum generating negative pressure,relative to atmospheric pressure, within the first fluid passageway;sealing the first fluid passageway to maintain the vacuum within thesource of bone-graft or bone-graft-substitute material; and moving thevalve so that a second fluid passageway between the source of bone-graftor bone-graft-substitute material and the liquid source is opened,wherein liquid from the liquid source is drawn into the second fluidpassageway and to the source of bone-graft or bone-graft-substitutematerial via the negative pressure generated during the using step. 2.The method of claim 1, wherein the valve assembly has internal channelsthat facilitate creation of the first and second fluid passageways,wherein at least some of the internal channels house the valve.
 3. Themethod of claim 2, further comprising the step of depressing the valvewithin at least one of the internal channels of the valve assembly, suchthat the first fluid passageway is opened via the valve.
 4. The methodof claim 3, wherein the valve is depressed against a compressible memberthat deforms to allow opening of the first fluid passageway.
 5. Themethod of claim 4, wherein the compressible member is resilient, and themethod further comprises forcing the compressible member against thevalve, such that the valve moves to a position in which the second fluidpassageway is opened and the first fluid passageway is scaled.
 6. Themethod of claim 2, wherein the valve comprises an opening through thevalve, and the method further comprises aligning the opening with atleast one of the internal channels of the valve assembly to open thesecond fluid passageway.
 7. The method of claim 6, wherein opening thefirst fluid passageway comprises moving the opening in the valve to aposition in which it is not aligned with the at least one of theinternal channels of the valve assembly.
 8. The method of claim 1,further comprising mixing the source of bone-graft orbone-graft-substitute material with the liquid source in a valveassembly containing the valve.
 9. The method of claim 1, wherein thesource of bone-graft or bone-graft-substitute material, the liquidsource, and the vacuum source are syringes connected to the valveassembly.
 10. The method of claim 9, wherein the vacuum is created byretracting a plunger of at least one of the syringes to generatenegative pressure within the valve assembly.
 11. The method of claim 10,wherein the syringes each contain Luer structure adapted to mate withcorresponding Luer structure on the valve assembly.
 12. The method ofclaim 1, wherein the bone-graft or bone-graft-substitute materialcomprises natural bone particles, particles of β-TCP, or hydroxyapatitecombined with β-TCP, each of such materials optionally includingbioactive glass, and the liquid source comprises water, saline, blood,bone marrow aspirate, or a combination thereof.
 13. The method of claim12, wherein the bone-graft or bone-graft-substitute material is mixedwith gelatin, collagen, micro-fibrillar collagen, or a combinationthereof.
 14. A method of mixing bone-graft or bone-graft-substitutematerial with one or more other components, the method comprising:providing a source of bone-graft or bone-graft-substitute material, anda source of liquid, at least one of the source of bone-graft orbone-graft-substitute material and the liquid source being incommunication with a vacuum source; providing a valve assembly havinginternal channels that facilitate creation of a first fluid passagewayand a second fluid passageway, the first fluid passageway being betweenthe vacuum source and the source of bone-graft or bone-graft substitutematerial, and the second fluid passageway being between the source ofbone-graft or bone-graft substitute material and the liquid source,wherein at least some of the internal channels house a valve, depressingthe valve within at least one of the internal channels of the valveassembly, such that the first fluid passageway is opened via the valve;using the vacuum source to create a vacuum between the source ofbone-graft or bone-graft-substitute material and the vacuum source, thevacuum generating negative pressure, relative to atmospheric pressure,within the first fluid passageway; sealing the first fluid passageway tomaintain the vacuum within the source of bone-graft orbone-graft-substitute material; and moving the valve so that a secondfluid passageway is opened, wherein liquid from the liquid source isdrawn into the second fluid passageway and to the source of bone-graftor bone-graft-substitute material via the negative pressure generatedduring the using step.
 15. The method of claim 14, wherein the valve isdepressed against a compressible member that deforms to allow opening ofthe first fluid passageway.
 16. The method of claim 15, wherein thecompressible member is resilient, and the method further comprisesforcing the compressible member against the valve, such that the valvemoves to a position in which the second fluid passageway is opened andthe first fluid passageway is sealed.
 17. The method of claim 14,wherein the valve comprises an opening through the valve, and the methodfurther comprises aligning the opening with at least one of the internalchannels of the valve assembly to open the second fluid passageway. 18.The method of claim 17, wherein opening the first fluid passagewaycomprises moving the opening in the valve to a position in which it isnot aligned with the at least one of the internal channels of the valveassembly.
 19. The method of claim 14, further comprising mixing thesource of bone-graft or bone-graft-substitute material with the liquidsource in the valve assembly.
 20. The method of claim 14, wherein thesource of bone-graft or bone-graft-substitute material, the liquidsource, and the vacuum source are syringes connected to the valveassembly.
 21. The method of claim 20, wherein the vacuum is created byretracting a plunger of at least one of the syringes to generatenegative pressure within the valve assembly.
 22. The method of claim 21,wherein the syringes each contain Luer structure adapted to mate withcorresponding Luer structure on the valve assembly.
 23. The method ofclaim 14, further comprising the step of engaging a syringe with thevalve assembly to automatically move the valve to a position in whichthe first fluid passageway is open, wherein the valve automaticallymoves to a position in which the first fluid passageway is closed oncethe syringe is retracted proximally along the valve assembly.
 24. Themethod of claim 14, wherein the bone-graft or bone-graft-substitutematerial comprises natural bone particles, particles of β-TCP, orhydroxyapatite combined with β-TCP, each of such materials optionallyincluding bioactive glass, and the liquid source comprises water,saline, blood, bone marrow aspirate, or a combination thereof.
 25. Themethod of claim 24, wherein the bone-graft or bone-graft-substitutematerial is mixed with gelatin, collagen, micro-fibrillar collagen, or acombination thereof.